17 May 2012

OraQuick HIV test: you can, but be careful

The US authorities approved the free sale of tests
to detect HIV at home

Copper newsDiagnostic tools for HIV infection, which can be used at home, have been approved by US supervisory authorities.

According to The Washington Times (FDA panel backs first rapid, take home HIV test), the corresponding decision was made by the American Food and Drug Administration (FDA).

The Advisory Commission of the department, which includes 17 experts, unanimously approved the free sale of OraQuick test systems. These OraSure Technologies products are designed to detect HIV in saliva, blood or blood plasma. Diagnosis of the presence or absence of antibodies to the immunodeficiency virus in the test material takes about 20 minutes.

At the same time, the FDA experts obliged the manufacturer to print a warning on the product packaging about possible errors in the diagnosis of HIV infection using OraQuick. In addition, the company was instructed to organize a free "hotline" for consumers who have a positive test result.

These conditions were due to the fact that during the OraQuick consumer tests, the diagnostic accuracy was 93 percent.

OraSure Technologies called this result natural, due to the use of tests by non-professionals. According to the company, the use of test systems by medical specialists provides the correct result in 99 percent of cases.

According to the FDA estimates, the mass use of OraQuick test strips in the United States will annually detect about 45 thousand HIV carriers, while 3.8 thousand Americans will receive a false result about the absence of the virus.

The management of the manufacturing company did not disclose the cost of test systems for consumers. Medical professionals can purchase OraQuick at a price of $17.5 apiece.

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